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New NIH Policy Protects Human Subjects in Research

Harvard researchers, students are now faced with the beurocracy in order to conduct research on students

"We recognize that this will create additional cost and burden to institutions," Seto says. "The whole topic of regulatory burden is being addressed by NIH."

The PHS proposal has the potential to create an even greater burden on universities, which would be required to certify they administer broad-based training to hundreds of employees.

Pascal says PHS is investigating the possibility of providing grant funding for the development of educational curricula for research institutions. It is also planning on posting material on the Internet that will help institutions to develop their curricula.

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The proposal is currently being revised by PHS, which plans to complete the guidelines in November, Pascal says.

According to Mitchell, the PHS policy would give universities two years to develop new educational programs, whereas the University had to comply with the NIH's new guidelines within four months of their announcement in June.

"Initially, we are waiting to see what comes out of Washington so we can design the scope of our program appropriately," Mitchell says.

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